When involved in phase III drug evaluation studies, which responsibilities would the nurse have?

Monitor and observe clients closely for adverse effects

Work with animals which are given experimental drugs

Make decisions that will determine the effectiveness of the drug

Select appropriate clients to be involved in the drug study

Answer and Explanation

The Correct Answer is A

a) Phase III clinical trials involve large groups of human participants and focus on confirming the drug's effectiveness and monitoring for adverse effects. The nurse plays a key role in observing and documenting any side effects experienced by the patients.

b) Working with animals is part of preclinical trials, not phase III studies. By the time a drug reaches phase III, it has already undergone animal testing.

c) While data collected in phase III trials contribute to determining a drug’s effectiveness, the decision-making is primarily done by researchers and regulatory agencies, not individual nurses.

d) Selection of appropriate clients for a drug study is generally determined by researchers and trial coordinators based on inclusion and exclusion criteria, rather than by nurses directly.

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Correct Answer is A

Explanation

A. Assessment is the first phase of the nursing process, during which the nurse gathers relevant patient data, such as allergies and lab values, to ensure safe medication administration. This step helps identify potential risks and contraindications.

B. Evaluation occurs after the medication has been administered and involves assessing the patient's response to the drug. In this case, the nurse is reviewing information before administration, making evaluation an incorrect choice.

C. Implementation refers to carrying out the nursing interventions, such as actually administering the medication. Since the nurse is still reviewing data, this step has not yet been reached.

D. Planning involves setting goals and determining appropriate interventions, but it does not include the direct collection of patient data. Reviewing lab values and allergies falls under the assessment phase.

A. To ensure a drug is tested for harmful effects. B. To ensure a drug has accurate labeling. C. To ensure a drug is free from adverse reactions. D. To ensure a drug is affordable. E. To ensure a drug is effective.

Correct Answer is ["A","B","E"]

Explanation

a) The FDA is responsible for overseeing the testing of drugs for harmful effects, including preclinical trials and clinical trials, to ensure that drugs do not cause unsafe side effects.

b) The FDA ensures that drugs have accurate labeling, including correct dosage, potential side effects, contraindications, and proper use.

c) The FDA does not guarantee that a drug will be free from adverse reactions. While they regulate and monitor drugs, adverse reactions can still occur after approval, and it is the responsibility of healthcare professionals and the manufacturer to monitor for these post-marketing.

d) The FDA does not ensure drug affordability; the pricing of drugs is influenced by many factors, including market forces, healthcare policies, and manufacturer decisions.

e) The FDA ensures that drugs are effective by overseeing clinical trials to demonstrate that the drug has the intended therapeutic effects for its indicated use.

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When involved in phase III drug evaluation studies, which responsibilities would the nurse have?

Nursing Test Bank

Naxlex Comprehensive Predictor Exams

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Correct Answer is A

Explanation

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Correct Answer is ["A","B","E"]

Explanation

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